Hydroxytriptolide in Active Rheumatoid Arthritis Patients With an Inadequate Response to Methotrexate

Phase 2CompletedNCT02202395

Shanghai Pharmaceuticals Holding Co., Ltd120 enrolled

Overview

The purpose of this study is to investigate the efficacy and safety of Hydroxytriptolide(LTS) in active rheumatoid arthritis patients with an inadequate response to methotrexate.

1. Investigate the efficacy of Hydroxytriptolide in active RA patients 2. Investigate the safety of Hydroxytriptolide in active RA patients. Especially in female reproductive system. 3. Population PK study.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

120

Conditions

Rheumatoid Arthritis

Interventions

LTS 0.25mgDRUG

use LTS 0.25mg/d

LTS 0.5mgDRUG

use LTS 0.5mg/d

LTS 1.0mgDRUG

use LTS 1.0mg/d

Placebo

Eligibility

Sex: FEMALEMin age: 35 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 35-65 years old, female, postmenopausal, parous, nulliparous with no fertility requirements * 1987 ACR Diagnostic criteria or 2009 ACR/EULAR Diagnostic criteria. X ray of Evaluable Joint in phase I/II/III, Joint Function in Phase I/II/III * Active RA * Continuously taking MTX for at least three months, ≥7.5mg/week. Before first study dose, keep in stable MTX dose for at least 4 weeks * Keep in stable NSAIDs dose or low-dose glucocorticoids for at least 4 weeks before first study dose * Using non-prohibited combination therapy, keep in stable dose for at least 7 days before first study dose * Using DMARD should have appropriate withdrawal period: * Withdrawal for 4 weeks: Sulfasalazine, Azathioprine, Chloroquine, \*Hydroxychloroquine, Auranofin, Penicillamine, Traditional Chinese medicine preparation(TGP, Sinomenine) * Withdrawal for 8 weeks: Leflunomide * Withdrawal for 8 weeks: Intramuscular, intravenous, intra-articular injection glucocorticoids * Women with fertility, negative in pregnancy test, and agreed to take contraceptive measures physical * Voluntary informed consent * Willing to follow the required regimen and schedule, follow-up examination Exclusion Criteria: 1. Currently suffering or have suffered from other inflammatory joint diseases, such as mixed connective tissue disease, scleroderma, systemic lupus erythematosus, ankylosing spondylitis, psoriatic arthritis, Reiter's syndrome, bone arthritis, rheumatoid arthritis, gouty arthritis, diagnosis of arthritis before 16yrs 2. With severe non-articular manifestations such as high fever, interstitial pneumonia, pleurisy, pericarditis, severe vasculitis, neuropathy, etc. 3. The evaluable joint underwent the surgical treatment within 2 months 4. Currently or recent have serious, or progression, or disease history not controled, including: liver, kidney, blood, gastrointestinal, endocrine, metabolic, respiratory, cardiovascular, nervous system diseases 5. Currently or have malignancy, lymphoproliferative disease history 6. Continuously use Tripterygium preparations for more than three months and have no effect 7. History of using TNF-a inhibitors of biological agents.(Adalimumab, infliximab, etanercept) 8. Severe or persistent infection within 3 months 9. X-ray shows active pulmonary infection 10. HBV, HCV, HIV, AIDS 11. WBC\<4.0×10\^9/L, PLT\<100×10\^9/L, Hb\<85g/L 12. AST\>2×ULN, ALT\>2×ULN 13. Cr\>135umol/L 14. Used oral contraceptive druds within 3 months 15. Pregnancy test was positive or lactating patients or patients with birth preparation 16. Have to use the prohibited drugs 17. With clinical symptoms of a serious history of drug abuse or alcohol abuse 18. History of any durg clinical trials within 3 months 19. Allergy to tripterygium 20. Other reasons depends by the investigator

Locations (5)

The first affiliated hospital of bengbu medical college

Bengbu, Anhui, China

Changzheng Hospital

Shanghai, Shanghai Municipality, China

Zhongshan Hospital Fudan University

Shanghai, Shanghai Municipality, China

Shanghai Jiaotong University School of Medicine, Renji Hospital Ethics Committee

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

Change from baseline in ACR 20 at 12 weeks and at 24 weeks

Time frame: 12weeks, 24weeks

Secondary Outcomes

Change from baseline in DAS 28 at 12 weeks and at 24 weeks

Time frame: 12weeks, 24weeks

The proportion of patients reached ACR50 at 12 weeks and 24 weeks

Time frame: 12weeks, 24weeks

The proportion of patients reached ACR70 at 12weeks and 24weeks

Time frame: 12weeks,24weeks

Change from baseline in swollen joint count at 12 weeks and 24 weeks

Time frame: 12weeks,24weeks

Change from baseline in tender joint count at 12weeks and 24weeks

Time frame: 12weeks,24weeks

Change from baseline in the duration of morning stiffness at 12 weeks and 24 weeks

Time frame: 12 weeks and 24 weeks

Change from baseline in rest pain at 12 weeks and 24 weeks

Time frame: 12weeks,24weeks

Change from baseline in PtGA patient global assessment at 12 weeks and 24 weeks

Time frame: 12 weeks and 24 weeks

Change from baseline in PGA physician global assessment at 12 weeks and 24 weeks

Time frame: 12 weeks and 24 weeks

Change from baseline in HAQ health assessment questionnaire at 12 weeks and 24 weeks

Data from ClinicalTrials.gov

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